Completing a Rescue Study Transition — How Much Time Do You Need?
Clinical Trials are large complex projects, and occasionally a sponsor may need to make a change to bring an underperforming project back on schedule. This type of change is not taken lightly by sponsors. Making such a transition takes time and a large investment in coordination and additional money. In this post, we will take you through a general scenario for a full-service contract research organization (CRO) transition. Our example will show when a sponsor fully transitions from the CRO currently running their study to a new CRO taking over and finishing it off. You may be wondering, “how long would that take?” After reading this article, you will have the answer based on generally accepted timetables.
Rescue studies come in all shapes and sizes. They can be done through seeking functional support. Optimizing aspects of the clinical trial or fully switching out the lead/sole CRO running your study. Communication problems between stakeholders, issues enrolling patients, or problems following protocols are usually to blame. The result is the same — a rescue study transition is deemed necessary by the sponsor to complete the research.
Understanding Rescue Studies and Timelines
Many of the things discussed in this article are transferable and relatable to the various rescue scenarios (functional, augmentation or full transition). In general, augmented rescue studies may take less time than a full transition. The length of rescue studies will depend on the complexity of the research and specific functions the CRO or vendor is going to take on.
1. Nailing Down the Issue & Seeking Management Buy-in (2–4 Weeks)
You know your study has a problem and you need to make a change. Nail down the issue(s) causing the problem with your current CRO and assemble a brief for your management team to secure their buy-in before approaching external rescue CROs/vendors.
- Why? We have seen numerous situations where sponsor staff spend months working with rescue CROs. They align their bids and put countless hours into a rescue package, but management does not support them. Make sure you have management support before embarking.
- Timeline — Building out a management briefing package and getting buy-in can take as long as 2–4 weeks. This timeline includes the efforts spent in creating the brief, the completion of your presentation, and reaching the final decision from management that will allow you to move forward in seeking out new CROs to support the study.
2. Building your Rescue Data Package (1–2 Weeks)
A rescue data package is the summation of information about your project which details all aspects of its current scope, the status of any work in process, and details who is responsible (vendor/sponsor) for all ongoing activities of your project.
- Why? If you want rescue bidders to provide accurate bids with the least amount of variation and versions, the rescue data package will be instrumental to achieving this.
- How? Watch the on-demand recording of Rescuing Your Study — A Sponsor’s Playbook.
- Timeline — Expect to spend as long as 1–2 weeks assembling documentation and preparing any reports that you plan to hand over to the CROs that will bid on your study for rescue or optimization services.
RESOURCE: For assistance building out your Rescue Data Package and its components, listen to our on-demand webinar — Rescuing Your Study — A Sponsor’s Playbook
3. Getting Quotes and Selecting Rescue CRO (6–8 weeks)
Once your rescue data package and any additional guidelines you generated are ready, it is time to send it out to CROs to obtain their budgets and rescue scenarios.
Timeline (6–8 weeks)
- When it comes to getting quotes and actually selecting a new CRO, budget around 6–8 weeks for the process. Rescue bidding is complex, and it is ideal to allow CROs 2–3 weeks to provide their initial proposal.
- If you really detailed your rescue data package (as described in the Rescue Study Playbook webinar), then you should be able to forgo multiple rounds of bidding.
- Bid Defenses: as part of your due diligence, you likely want to bring in the rescue CROs bidding to size up their team and strategy face-to-face. Let them know one is expected and timing needed in your RFP materials.
- Pre-negotiate MSA: send your MSA template or have the CROs provide their own MSA template as part of the bidding process. This will help you expedite the eventual contracting process to save time.
- Brief your management on the selected CRO and why: take them through the financials, updated timeline and the criteria you are using to select the best CRO. Ensure you have their support and that they know what is coming next.
4. Executing Agreement with CRO (2–4 weeks)
Once you have selected a new CRO, you will need to prepare and execute an agreement with that firm or organization.
- Timeline — Expect to spend anywhere from 2–4 weeks on finalizing your MSA, budget and fully scoped contract with your new rescue CRO.
- Hold a scope review call: Walk through every budget line item to ensure accuracy (schedule 2 hrs and hold it over WebEx). Especially important, if not done during the bidding process and review period.
- Draw a line in the sand: Rescue scope will continue to change since you are dealing with a moving target/ongoing study. Use the scope review call to nail your rescue scope and budget down for initial contract purposes.
- A rescue budget reconciliation update after the rescue transition is complete: Know this at initiation and keep a change in scope log as you go through the rescue period, so you can reconcile more easily.
- For rescues, avoid start-up agreements: The temptation is there, but you will be in perpetual contract negotiation and that’s not fun for anyone, especially you. It is critical that you, the sponsor, have a full understanding of rescue cost as well as the value of the transition. Start-up agreements can cause impediments and make things more complex from a scope management perspective. A fully-scoped contract is the best way to start. The reconciliation (mentioned earlier) after the transition is complete is the best way to then clean-up/update your scoped agreement and budget.
5. Starting Transition and Completion of Transition with CROs (1–6 months)
Once the new CRO is fully contracted, it is time to begin the study transition. Note that the timeline for transition is entirely dependent on the scope of project services being transitioned and the complexity of your study.
A full-service study transition for a global study (with 50+ sites) will likely push you towards the six-month window. This would mean that all work is handed over, operations are 100% back to normal, and the CRO that was underperforming is now off the project entirely.
Rescue studies are complex to manage and take time to complete. We hope this blog article provides you with some value for your own rescue study planning. Having a firm understanding of the potential timeline, will help make your job easier as you manage the transition.
Pharm-Olam has rescued over 100 projects, so we have seen many of these issues first-hand — and we are in a position to help you move past them. If your study is in trouble, see how our rescue study services can help you hit important milestones and goals.
Originally published at https://www.pharm-olam.com.